[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07714239":3,"trial-entities:NCT07714239":119,"trial-summary:NCT07714239":123},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":45,"secondary_outcomes":50,"sex":73,"minimum_age":74,"maximum_age":75,"healthy_volunteers":15,"eligibility_criteria":76,"std_ages":87,"locations":90,"central_contacts":108,"overall_officials":115,"references":117,"see_also_links":118},"NCT07714239","QUX 26-006","Pharmacist-Assisted Titration of Rx to Implement Optimal Medical Therapy for Heart Failure","Pharmacist-Assisted Titration of Rx to Implement Optimal Medical Therapy for Heart Failure (PATRIOT-HF) (QUE 25-018)","NOT_YET_RECRUITING","2030-09-30","2026-07","2026-07-20","2026-07-24","VA Office of Research and Development","FED",false,"Many Veterans who are hospitalized with heart failure do not receive all the recommended heart medications at the right doses before they leave the hospital or in the weeks following discharge. This study tests whether a team of clinical pharmacists and cardiologists, working virtually, can improve heart failure medication prescribing for Veterans at VA medical centers. The pharmacist and cardiologist team reviews patient records and provides recommendations to the treating doctors and primary care providers caring for Veterans with heart failure. The goal is to increase use of guideline-recommended medications, which have been shown to improve survival, reduce hospitalizations, and improve quality of life.","Heart failure with reduced ejection fraction (HFrEF) affects a large proportion of Veterans and isa leading cause of hospitalization and death. Clinical guidelines recommend four classes of medications (commonly called \"quadruple therapy\") that improve survival and reduce hospitalizations, yet 42% of Veterans hospitalized with heart failure do not receive all recommended medications at discharge.\n\nThis study implements a virtual pharmacist and cardiologist team (hub) that provides digital consultation to hospitalists and primary care providers (spoke) at VA medical centers regarding use of guideline-directed medical therapy (GDMT) during hospitalization and the post-discharge period. The pharmacist\u002Fcardiologist team identifies eligible Veterans using a VA hospital-specific dashboard, reviews electronic health records, and places digital consultation notes with individualized medication recommendations, safety surveillance information, and out-of-pocket medication cost data.\n\nThe intervention also incorporates identification of Veterans hospitalized in VA-paid community care settings. Veterans hospitalized with heart failure in community hospitals within the preceding 3 months are identified via VA-paid community care claims data, and actionable recommendations are provided through the VA electronic health record or by facsimile to community providers.\n\nSix VA medical centers served by Clinical Resource Hubs in VISNs 4, 16, 17, 19, and 23 are participating. Sites are randomized to one of three implementation waves in a cluster-randomized stepped-wedge design, with implementation occurring every 6 months at two sites per wave. This design allows estimation of intervention effects using both within- and between-site comparisons while controlling for secular trends. A difference-in-differences analytic approach with covariate-constrained randomization is used to estimate causal effects.\n\nThe primary effectiveness outcome is change in GDMT optimization score from admission to 14 days after discharge. Secondary effectiveness\u002Fsafety outcomes include mortality, heart failure readmission, and medication-related adverse events at 90 days. Implementation outcomes are assessed using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework and include fidelity to identification of at-risk Veterans, provision of recommendations,, outpatient follow-up rates, and barriers and facilitators to implementation Additional outcomes derived from the RE-AIM framework will also be captured.",[19,20],"Heart Failure","Heart Failure, Systolic",[22,23,24,25,26,27,28],"Guideline-Directed Medical Therapy","Pharmacists","Medication Therapy Management","Quality Improvement","Veterans Health","Telemedicine","Implementation Science","INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[32],"NA",{"count":34,"type":35},585,"ESTIMATED",[37],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":43},"BEHAVIORAL","Pharmacist\u002FCardiologist Virtual Team Digital Consultation","A centralized pharmacist and cardiologist virtual team (hub) provides protocol-based digital consultation notes to inpatient and outpatient providers(spoke) regarding initiation and intensification of guideline-directed medical therapy (GDMT) for heart failure during hospitalization and the post-discharge transitional care period. Eligible Veterans are identified via VA dashboards and community care claims data. Recommendations cover quadruple therapy (beta blockers, ACEI\u002FARB\u002FARNI, MRA, SGLT2i) and are tailored to individual clinical presentations. The pharmacist arranges outpatient follow-up and delivers medication adherence education.",[42],"Pharmacist\u002FCardiologist Virtual Team (Intervention)",[44],"PATRIOT-HF intervention; pharmacist-assisted GDMT optimization",[46],{"measure":47,"description":48,"timeFrame":49},"Change in Guideline-Directed Medical Therapy (GDMT) Optimization Score","The GDMT Optimization Score reflects the proportion of eligible guideline-recommended heart failure medications prescribed relative to the total for which the Veteran is eligible. Points are assigned as follows - Numerator: ACEI\u002FARB=1, ARNI=2, evidence-based beta blocker=2, MRA=2, SGLT2i=2, Vericiguat=1, Ivabradine=1, Hydralazine\u002FNitrates=1. Denominator reflects eligibility for each class. A higher score indicates greater concordance with guidelines.","From hospital admission (baseline) to 14 days after discharge (VA direct care) or 14 days after Veteran eligibility identification (VA community care)",[51,55,59,62,66,70],{"measure":52,"description":53,"timeFrame":54},"Change in NIH Heart Failure Collaboratory Score","A composite GDMT metric assessing the breadth and completeness of guideline-recommended heart failure pharmacotherapy.","From hospital admission (baseline) to 14 days after discharge (VA direct care) or Veteran eligibility identification (VA community care)",{"measure":56,"description":57,"timeFrame":58},"All-cause mortality","Death from any cause, ascertained from the VA Death Ascertainment File.","30 days and 90 days after hospital discharge (VA direct care) or Veteran eligibility identification (VA community care)",{"measure":60,"description":61,"timeFrame":58},"Heart Failure Readmission","A claim for inpatient admission with any HF diagnosis on the claim, ascertained from the VA Corporate Data Warehouse and Consolidated Data Set.",{"measure":63,"description":64,"timeFrame":65},"Medication-related adverse outcomes - acute kidney injury","Acute kidney injury identified by creatinine levels and ICD diagnostic codes in the VA Corporate Data Warehouse.","90 days after hospital discharge or Veteran eligibility identification",{"measure":67,"description":68,"timeFrame":69},"Medication-related adverse outcomes - bradycardia","Bradycardia identified by vital sign readings and ICD diagnostic codes in the VA Corporate Data Warehouse.","90 after hospital discharge or Veteran eligibility identification",{"measure":71,"description":72,"timeFrame":65},"Medication-related adverse outcomes - hyperkalemia","Hyperkalemia identified by potassium laboratory values and ICD diagnostic codes in the VA Corporate Data Warehouse.","ALL","18 Years",null,{"inclusion":77,"exclusion":83,"raw_text":86},[78,79,80,81,82],"Admission to a VA medical center or VA-paid community hospital within the preceding 3 months with a primary diagnosis of heart failure","The primary study cohort will consist of those admitted to a VA medical center, while the secondary study cohort will consist of patients admitted to VA-paid community hospitals","Left ventricular ejection fraction ≤ 40%","Not on optimal guideline-directed heart failure medication classes or doses, as assessed in the electronic health record","Receiving care within one of the 6 participating VA medical centers",[84,85],"Hemodynamic instability","Receiving comfort care measures alone or enrolled in hospice","Inclusion Criteria:\n\n* Admission to a VA medical center or VA-paid community hospital within the preceding 3 months with a primary diagnosis of heart failure\n\n  * The primary study cohort will consist of those admitted to a VA medical center, while the secondary study cohort will consist of patients admitted to VA-paid community hospitals\n* Left ventricular ejection fraction ≤ 40%\n* Not on optimal guideline-directed heart failure medication classes or doses, as assessed in the electronic health record\n* Receiving care within one of the 6 participating VA medical centers\n\nExclusion Criteria:\n\n* Hemodynamic instability\n* Receiving comfort care measures alone or enrolled in hospice",[88,89],"ADULT","OLDER_ADULT",[91],{"facility":92,"city":93,"state":94,"zip":95,"country":96,"contacts":97,"geoPoint":105},"Rocky Mountain Regional VA Medical Center, Aurora, CO","Aurora","Colorado","80045-7211","United States",[98,103],{"name":99,"role":100,"phone":101,"email":102},"Paul L Hess, MD MS","CONTACT","720-857-6889","paul.hess@va.gov",{"name":99,"role":104},"PRINCIPAL_INVESTIGATOR",{"lat":106,"lon":107},39.72943,-104.83192,[109,111],{"name":99,"role":100,"phone":110,"email":102},"(720) 857-6889",{"name":112,"role":100,"phone":113,"email":114},"Lexus L Ujano-De Motta, BS","(808) 990-3993","lexus.ujano-demotta@va.gov",[116],{"name":99,"affiliation":92,"role":104},[],[],{"nct_id":4,"conditions":120,"biomarkers":122},[121],"Unspecified Systolic Congestive Heart Failure",[],{"nct_id":4,"found":124,"summary":125,"prompt_version":135},true,{"design":126,"status":127,"heading":128,"summary":129,"follow_up":130,"word_count":131,"commitments":132,"compensation":133,"drugs_mentioned":134},"This interventional study plans to enroll 585 participants. It involves a virtual team providing digital consultation notes.","completed","Pharmacist-Assisted Titration for Heart Failure in Veterans","This study is testing if a virtual team of pharmacists and heart doctors (cardiologists) can help Veterans with heart failure get the right medications at the right doses. Many Veterans hospitalized for heart failure don't receive all recommended medications before leaving the hospital or soon after. The virtual team reviews patient records and provides recommendations to the Veteran's treating doctors. The goal is to increase the use of guideline-recommended medications, which are known to improve survival, reduce hospital stays, and improve quality of life for people with heart failure. You might be able to join if you are a Veteran aged 18 or older who has been hospitalized for heart failure with a left ventricular ejection fraction (a measure of how well your heart pumps blood) of 40% or less within the last three months. The study is currently unclear on its recruitment status.","Your medication optimization will be measured from hospital admission to 14 days after discharge or eligibility identification.",144,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]